BEUDAMED
    Product Code: NKB FDA class 2 21 CFR 888.3070

    Thoracolumbosacral Pedicle Screw System

    Orthopedic

    The Thoracolumbosacral Pedicle Screw System is an orthopedic implant intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to spinal fusion surgery. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKB and regulation 21 CFR 888.3070 in the Orthopedic specialty. The device is flagged as an implant but is not life-sustaining.

    View on FDA
    510(k)s
    901
    FEI Numbers
    407
    Registration Numbers
    407
    Unique Applicants
    275
    Years Active
    23

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    Basic Information

    Product Code
    NKB
    Device Class
    FDA class 2
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 901 510(k) clearances via K numbers.

    K Number Device Name
    K253045 “Socko” Vimax Spinal Fixation System
    K251251 ChanPin Pedicle Screw Spinal System
    K260989 Varion Thoracolumbar Fixation System
    K253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
    K261130 AccelFix Spinal Fixation System
    K253966 PERLA® TL Posterior Thoraco-lumbar Fixation System
    K252542 LEO Spinal System
    K253940 M.U.S.T. Pedicle Screw System - Extension
    K260216 CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System
    K254274 ARx® SAI Implant System
    K260786 KHEIRON® Spinal Fixation System, including patient specific K-ROD
    K254247 OSTEOMNI SPINAL FIXATION SYSTEM
    K253169 Duet™ Spinal Fixation System
    K253545 Vulcan Spinal System
    K252461 Swedge™ Pedicle Screw Fixation System Bezier Rod
    K253990 KHEIRON® Spinal Fixation System, including patient specific K-ROD
    K253941 CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
    K253721 KHEIRON® Spinal Fixation System, including patient specific K-ROD
    K253093 Vital™ Spinal Fixation System
    K252729 Universal Spinal System
    K253335 CD Horizon™ Spinal System
    K252730 Fule Spinal Fixation System
    K253249 TriALTIS™ Spine System
    K252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
    K242827 A8 INTEGR8™ Porous Pedicle Screws
    K253331 PressON Spinal Fixation System
    K252437 JAZZ Spinal System
    K251804 KHEIRON® Spinal Fixation System, including patient specific K-ROD
    K251719 Momentum® Posterior Spinal Fixation System
    K250908 Virata Spinal Fixation System
    K251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
    K251131 Annex® 2 Adjacent Level System
    K250582 COLONNADE Posterior Screw Fixation System
    K241663 Eminent Spine 3D Titanium Pedicle Screw System
    K250092 HC Biologics Osteopoint Spinal Fixation System
    K242900 VADER® Pedicle System and VADER®one Pedicle System
    K243916 Primus Spinal Fixation System
    K243908 Tiger 2 System
    K243249 TriALTIS™ Spine System
    K243946 EffortMed Spinal Fixation System
    K243259 MASADA Modular Spinal Fixation System
    K243693 NEO Pedicle Screw System™
    K242297 Reform Pedicle Screw System
    K243281 LOCK-IN Spinal Fixation System
    K231655 4CIS® Chiron Spinal Fixation System
    K242764 MediRod Pedicle Screw System
    K243004 Xpine Spinal Fixation System
    K243106 CarboClear® Hybrid Pedicle Screw System
    K242350 Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
    K243007 CD Horizon™ Spinal System
    K242899 NOVA Minimally Invasive System
    K230325 GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
    K241657 MSFX MIKRON SPINAL FIXATION SYSTEM
    K242042 TriALTIS™ Spine System
    K240233 Pitkar Spinal Pedicle Screw System
    K242069 Eminent Spine Scoliosis Deformity Pedicle Screw System
    K240180 Orthopeasia Spinal Fixation System
    K241892 Cortera™ Spinal Fixation System
    K233793 CarboClear® X Pedicle Screw System
    K241494 Pantheon Pedicle Screw and Iliac Bolt Fixation System
    K241863 Erisma® Lp Spinal Fixation System; Erisma® LP MIS
    K241519 Invictus® Small Stature Spinal Fixation System
    K240963 Spinal System
    K241258 Ingenix Spinal System
    K241276 Vector™ Pedicle Screw System
    K240685 Salvo® Spine System
    K240392 JAZZ Spinal System
    K240526 POWEReam Xia/Serrato
    K240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
    K240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
    K232566 NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
    K240737 G Surgical Marksman MIS System
    K240350 AnyPlus II Spinal Fixation System
    K233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
    K240539 Vital™ Spinal Fixation System
    K232607 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
    K232628 VADER® Pedicle System
    K234048 M.U.S.T. Pedicle Screw System - Extension
    K233960 INNOVERSE Spinal System
    K233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
    K233300 POWEReam 1/4 Drive
    K233684 TriALTIS™ Spine System
    K233455 ARx MIS Spinal Screw System
    K232719 ProMIS Extension Rod System
    K231443 Mini-OSTEO Pedicle Fixation System
    K231694 MASADA Modular Spinal Fixation System
    K233234 PressON Spinal Fixation System
    K231737 ANAX™ 5.5 Spinal System
    K231069 PERLA® TL Posterior Thoraco-lumbar Fixation System
    K232586 Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
    K232561 Ripley Spinal Screw System by SAGICO
    K231744 VyLink™ Spinal Screw System
    K230116 Vital™ Spinal Fixation System
    K232341 CarboClear® Pedicle Screw System
    K231658 VEOS Spinal Fixation System
    K230961 Zeus Spinal System
    K232650 KHEIRON® Spinal Fixation System, including patient specific K-ROD
    K232275 Invictus® Spinal Fixation System
    K231479 TriALTIS Spine System
    K230974 NIDO™ Pedicle Screw System
    K232218 Zenius™ Spinal System
    K231811 Zavation Connector System
    K232141 CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
    K232311 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
    K231098 LineSider® Spinal System
    K231931 Adena-Zina Spinal System
    K231799 INERTIA® CONNEXX™ Modular Pedicle Screw System
    K231844 ProMIS™ Fixation System
    K223806 VERTICALE® Triangular Fixation System
    K231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
    K231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
    K230762 EDEN Spinal Fixation MIS System
    K222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi
    K223096 Dark Star Deformity Pedicle Screw System
    K222229 Advanced LumFix Spinal Fixation System
    K223529 PressON Spinal Fixation System
    K212220 ArtFX Spinal Fixation System
    K230766 Altus Spine Monaco Pedicle Screw System
    K230482 Swedge™ Pedicle Screw Fixation System
    K222105 RESPONSE 5.5/6.0 Cannulated Screw System
    K230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System
    K230063 G Surgical Marksman Spinal Deformity System
    K223494 CD Horizon Spinal System
    K223181 NuVasive Reline System
    K223565 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
    K223273 ASTRA Spine System
    K222614 Zavation Spinal System
    K222516 Mercury® II Spinal System
    K223274 Momentum® MIS Posterior Spinal Fixation System
    K212700 Dyflex-II
    K222031 Spinal Inner Fixation System
    K222415 Rexious Spinal Fixation System
    K222473 EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
    K221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM
    K220297 True Tulip, True M.I.S.
    K211027 Altus Spine Pedicle Screw System
    K222110 Mariner RDX System
    K221745 Sterile Posterior Spinal Fixation System
    K222362 Salvo® Spine System
    K221403 Cortera Spinal Fixation System
    K221776 NextGen Pedicle Screw System
    K221905 INERTIA CONNEXX Modular Pedicle Screw System
    K221332 OsteoCentric Spine MIS Pedicle Fastener System
    K220486 Kentrospine PSS Pedicle Screw System
    K201788 EDEN Spinal Fixation System
    K211981 KHEIRON® Spinal Fixation System
    K203233 4CIS Chiron Spinal Fixation System
    K221244 CD Horizon™ Spinal System
    K220285 PINE Pedicle Screw System
    K220341 ARx Modular Spinal System
    K220724 CD Horizon™ Spinal System and PASS LP™ Spinal System
    K214006 Invictus® Spinal Fixation System
    K220025 ARx® Spinal System
    K220374 EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
    K213750 VyLink™ Spinal Screw System
    K212627 True Tulip, True M.I.S.
    K213470 PERLA® TL Posterior Osteosynthesis System
    K213281 PASS LP™ Spinal System, CD Horizon™ Spinal System
    K213460 Invictus Spinal Fixation System
    K212692 Mariner Pedicle Screw System
    K203607 MOSS VRS Spinal System
    K212185 Golden Isles Pedicle Screw System
    K212066 Adena-Zina System
    K211414 KHEIRON Spinal Fixation System
    K211958 CD Horizon Spinal System
    K210963 ENNOVATE Spinal System
    K203023 Pisces Spinal System
    K211113 Zavation Spinal System
    K211606 Mariner Deformity System
    K201737 Posterior Spinal Fixation System
    K211323 ASTRA Spine System
    K210306 GII Spinal Fixation System
    K210816 True Tulip, True M.I.S.
    K210874 Reliance Spinal Screw System
    K210637 CD Horizon™ Spinal System
    K210549 ARx Spinal System
    K210427 M.U.S.T. Midline Cortical (MC) Screw System
    K210420 Goblin and Goblin LS Pedicle Screw Systems
    K210539 CoreLink Midline Fixation System
    K210716 CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
    K201457 Auxein Brand Vertaux 5.5 mm Pedicle Screw System
    K210275 Polaris Spinal System
    K201420 Republic Spine Dark Star Spinal System
    K202498 4CIS SARA Spine System, 4CIS VERTU Spine System
    K203507 Vitality® Spinal Fixation System
    K203482 M.U.S.T. Pedicle Screw Extension and Long Tab Implants
    K200922 Altus Spine HA Pedicle Screw System
    K203153 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
    K203506 PERLA® TL posterior osteosynthesis system
    K202505 GetSet Surgical GoPLF! Posterior Lateral Fusion System
    K203452 Nano FortiFix® System
    K203222 PERLA TL Posterior Osteosynthesis System
    K203163 ARx Illiac Spinal Screw System
    K200789 LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
    K203367 LineSider™ Spinal System
    K203317 CarboClear X Pedicle Screw System
    K203056 Invictus™ Spinal Fixation System
    K201568 Calvary Spine Pedicle Screw System
    K202476 Salvo® Spine System
    K200790 LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
    K202528 Cannulated Power Driver Attachment
    K200937 ACURA Stabilization System
    K202894 Wiltrom Spinal Fixation System
    K201427 Trivergent Spinal Fixation System
    K200794 AccelFix Spinal Fixation System
    K202771 CD Horizon Spinal System
    K202327 Invictus™ OsseoScrew® System
    K201659 KHEIRON® Spinal Fixation System
    K201407 CD Horizon™ Spinal System
    K202328 CD Horizon Spinal System
    K190600 ORION Spinal System
    K200981 Mega Plus MIS Spine System
    K201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
    K201648 Sterispine™ PS
    K201780 True Tulip System, True M.I.S. System
    K201751 Pedicle Screw System
    K190408 Spinal Fixation System
    K200322 Altus Spine Pedicle Screw System
    K193423 VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
    K200303 Reform Pedicle Screw System
    K192930 Dymaxeon Spine System
    K200519 CarboClear® II Pedicle Screw System
    K200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
    K200666 Stryker Xia 3 Power Adaptor
    K200070 ARx Spinal System
    K193100 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System
    K193211 Nano FortiFix® System
    K200267 LOSPA® IS™ Spinal Fixation System
    K191655 MEGAFIX® Pedicle Screw Spinal System
    K200381 Daytona® Small Stature Spinal System
    K193472 OrthoCircle Spine Pedicle Screw System
    K193396 PERLA® TL posterior osteosynthesis system
    K193270 CapLOX II®/TowerLOX® MIS Pedicle Screw System
    K193365 M.U.S.T. Pedicle Screw System
    K190981 NEX-D2 Posterior Fixation System
    K192800 Streamline TL Spinal Fixation System
    K193465 CorticaLINK Spinal Fusion Platform
    K193011 CD Horizon™ Fenestrated Screw Set
    K192680 Percusys® Plus Pedicle Screw System
    K193219 G Surgical Marksman System
    K192938 Invictus™ Spinal Fixation System
    K192396 Streamline MIS Spinal Fixation System
    K192915 GMA 2.0 Pedicle Screw System
    K192121 Black Diamond Pedicle Screw System
    K192268 Europa Pedicle Screw System
    K190636 NuVasive® Reline® 4.5-5.0 System
    K191932 Momentum™ Posterior Spinal Fixation System
    K191576 Mercury® Spinal System, Overwatch® Spinal System
    K191726 mont blanc & mont blanc MIS Spinal Systems
    K191810 Curiteva Pedicle Screw System
    K191494 Facilis™ Spinal System
    K191575 ARx Spinal System
    K191835 CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
    K183091 Elaris Pedicle Screw System
    K190471 4CIS® Chiron Spinal Fixation System
    K191757 EUROPA Pedicle Screw System
    K191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation System
    K191045 Salvo™ Spine System
    K190360 LineSider™ Spinal System
    K190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
    K190762 The JASPER Spinal Fixation System II
    K182416 NOVA Minimally Invasive System
    K182544 AccelFix Spinal Fixation System
    K183639 Mariner Outrigger Revision System
    K190567 KeYi Spinal Fixation System
    K190376 PASS LP Spinal System
    K190317 Zavation Spinal System
    K183550 Vitality® Spinal Fixation System
    K182375 CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
    K190361 Zavation Spinal System
    K180337 EUROPA Pedicle Screw System
    K183430 Modular Spinal Fixation System
    K182771 ISS-JAZZ Screw System and JAZZ CAP SP
    K182974 NuVasive Reline System
    K180626 Pedimax II - Pedicular Screw Spinal System
    K182970 EUROPA™ Pedicle Screw System
    K182478 Whistler Modular Pedicle Screw System
    K181824 CBT Screw Fixation System
    K182954 Salvo™ Spine System
    K182339 LEUCADIA AUTOLOK™ Pedicle Screw System
    K183168 OpenLoc-L Spinal Fixation System
    K183080 Mega Plus Spine System
    K180754 C-Zero Pedicle Screw System, Freedom Pedicle Screw System
    K183117 PathLoc-L MIS Spinal System
    K182598 VersaLink™ Fixation System
    K180980 ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System
    K182283 FUSE Pedicle Screw System
    K182239 OLYMPIC Posterior Spinal Fixation System
    K182240 PASS LP Spinal System
    K172826 Cellent Spinal Systems
    K182059 Prase MIS Spinal System
    K182377 CarboClear® Pedicle Screw System
    K181980 OsseoScrew System
    K181995 Chiral Surgical Pedicle Screw System
    K181390 Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
    K181821 MOSS VRS Spinal System
    K182119 CD HORIZON™ Spinal System
    K180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw
    K181978 Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
    K181584 Redi-Spine
    K181677 Kodiak Spinal Fixation System
    K181554 Stowe Pedicle Screw System
    K181495 Republic Spine Dark Star Spinal System
    K180226 TREND II Spinal Fixation System- STEP Series
    K181339 Altus Spine Pedicle Screw System
    K173645 JASPER Spinal Fixation System
    K173487 CarboClear® Pedicle Screw System
    K180655 Viking Lumbar Polyaxial Screw System
    K181139 OLYMPIC Posterior Spinal Fixation System
    K181119 Range (Denali and Mesa) Spinal Systems
    K181281 Altus Spine Pedicle Screw System
    K181188 EVEREST Spinal System
    K180220 SAGICO OSI Spinal System by Osimplant
    K180686 SeaSpine Daytona Small Stature Spinal System
    K180433 ENNOVATE®
    K180458 FOCUS Pedicle Screw System
    K180301 AXIS 5.5 Lumbar Pedicle Screw System
    K172967 Mercury® Spinal System
    K180324 Patriot Spinal Fixation System
    K180376 K2M Patient Specific Rods
    K180210 CREO® Stabilization System
    K180475 CapLOX II® / TowerLOX® MIS Pedicle Screw System
    K180153 X-spine Cortical Bone Screw System
    K173180 Mega Plus Spine System
    K173249 CD HORIZON™ Spinal System
    K172267 IRENE Thoracolumbar Fixation System
    K180176 SeaSpine NewPort Spinal System
    K173185 SEURAT™ Universal Pedicle Screw System
    K173882 SeaSpine Mariner Pedicle Screw System
    K173814 DeGen Medical E3 MIS Pedicle Screw System
    K172548 Wiltrom Spinal Fixation System
    K171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
    K173508 Everest Spinal System
    K173130 Reform® Midline Cortical Screw System
    K173524 ANAX 5.5™ Spinal System
    K173484 CorticaLINK Spinal Fusion Platform
    K173131 Rexious Spinal Fixation System
    K173126 Arisstos™ Spinal System
    K173522 Solanas® Posterior Stabilization System
    K172469 TiLock Modular Spinal System
    K173095 VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
    K172808 CosmoLock Pedicle Screw System
    K172546 AnyPlus® Spinal Fixation System
    K172724 XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
    K171894 NuVasive® Precept™ Spinal System
    K172275 Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
    K172101 ROMEO® 2 Posterior Osteosynthesis System
    K171832 Range/Denali/Mesa Spinal System
    K171582 NEO Pedicle Screw System™
    K171570 Additional VIPER PRIME™ screws with fenestrations
    K172107 Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System
    K171526 Zenius™, lliad™ and Kora™ Spinal Fixation Systems
    K172175 CapSure® PS System
    K161225 Paonan Armstrong Posterior Spinal Fixation System
    K170861 Premier
    K171456 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
    K171758 M.U.S.T. Combined Set Screws
    K171559 True Spinal Fixation System
    K171838 TiLock2 Spinal System
    K171907 Vitality® Spinal Fixation System
    K170710 True Spinal Fixation System
    K171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
    K163011 PHA S1 Spinal System
    K170045 Swedge™ Pedicle Screw Fixation System
    K171509 Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
    K170821 ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
    K171438 Palisade™ Pedicular Fixation System
    K171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
    K170611 SETx Pedicle Screw System
    K170989 Dymaxeon Spine System
    K170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
    K170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
    K171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
    K170543 VIPER PRIME™ Screws with Fenestrations
    K170108 Xultan 5.5 Pedicle Screw System
    K170964 Zenius Spinal System
    K170942 The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
    K170268 Fortress™ Pedicular Fixation System
    K170266 Palisade™ Pedicular Fixation System
    K170255 Threshold™ V2 Pedicular Fixation System
    K170251 Threshold™ Pedicular Fixation System
    K163363 SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
    K170347 CD HORIZON™ Fenestrated Screw Set
    K163096 GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
    K162995 Ibis® Pedicle Screw System
    K170654 USS System
    K170528 Sterispine™ PS
    K170126 NuVasive® Reline® 4.5-5.0 System
    K163604 SeaSpine® Daytona® Small Stature Spinal System
    K163056 Revolution™ Spinal Fixation System
    K170163 Erisma® LP Spinal Fixation System
    K163566 Hubble I System
    K170061 ProMIS™ Fixation System
    K162786 PASS LP Spinal System
    K161231 Facilis™ Spinal System
    K162764 JAZZ FRAME SYSTEM
    K163301 CD HORIZON® Spinal System
    K162134 ENNOVATE Spinal System
    K162912 VIPER PRIME™ additions to the VIPER® System
    K162160 Preference Elite Pedicle Screw System
    K162232 MOSS 100 Pedicle Screw System
    K162379 CD HORIZON® Spinal System
    K162576 FORTEZZA Spinal Stabilization System
    K162750 Libra Pedicle Screw System
    K162367 Erisma® LP MIS
    K162061 M.U.S.T. Pedicle Screw System
    K161842 Overwatch Spine System
    K162494 CD HORIZON® Spinal System
    K161014 NuVasive® Reline® System
    K160640 PASS XS Spinal System
    K161535 SeaSpine® NewPort™ Spinal System
    K161516 G Surgical Marksman MIS System
    K161766 PathLoc-L MIS Spinal System
    K161914 Genesys Spine TiLock Cortical Spinal System
    K161387 Mont Blanc and Mont Blanc MIS Spinal Systems
    K161627 PASS LP Spinal System
    K161499 VertiForm Posterior Fixation System
    K161369 EVEREST Spinal System
    K161694 Threshold™ Pedicular Fixation System
    K152920 Savannah-T® Pedicle Screw System
    K160722 CorticaLINK Spinal Fusion Platform
    K160904 Expedium Spine System, VIPER and VIPER 2 Systems
    K160926 F1 MPS Modular Pedicle Screw System
    K160820 PressON Pro Spinal Fixation System
    K161363 Arsenal Spinal Fixation System
    K160989 NuVasive® Reline® System
    K160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
    K160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
    K160902 Mariner Pedicle Screw System
    K160226 JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
    K160986 Xenco Medical Pedicle Screw System
    K153152 Syzygy Stabilization System
    K153453 Inertia Pedicle Screw and Deformity Correxxion System
    K160216 Revolution Spinal Fixation System
    K153413 PASS LP Spinal System
    K151704 Diplomat® Spinal System
    K151977 icotec Pedicle System
    K160466 Response 5.5 Spine System
    K153326 Erisma-LP Spinal Fixation System
    K153323 Palisade Pedicular Fixation System
    K153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
    K152781 Adena-Zina System
    K153589 CD HORIZON Spinal System
    K153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
    K153525 Seneka II Polyscrew Pedicle Fixation System
    K153664 M.U.S.T. Pedicle Screw System
    K153463 CD HORIZON Spinal System, IPC POWEREASE System
    K152968 Arsenal Spinal Fixation System
    K152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
    K151770 Libra Pedicle Screw System
    K153031 RANGE/DENALI/MESA Spinal System
    K151974 Polaris Spinal System
    K152248 CD HORIZON Spinal System
    K152039 Genesys Spine TiLock2 Spinal System
    K152457 CD HORIZON Spinal System
    K151648 Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
    K151921 STERISPINE PS
    K151747 STERISPINE PS
    K151849 Seneka I Polyscrew Pedicle Fixation System
    K151727 Everest Spinal System
    K151733 Xenco Medical Pedicle Screw System
    K152148 Fortress Pedicular Fixation System
    K150896 Vitality Spinal Fixation System
    K151422 Reform Pedicle Screw System
    K151216 Everest Spinal System
    K150380 ProMIS Fixation System
    K151196 Nautilus Spinal System
    K151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
    K150856 Reform Pedicle Screw System
    K143110 GALAXY MIS Screw System
    K142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
    K150184 Dymaxeon Spine System
    K142835 Iliad Pedicle Screw System and Zenius Pedicle Screw System
    K151215 Mercury Spinal System
    K150600 Response 5.5/6.0 Spine System
    K143683 APEX-DL Spine System
    K150417 ASTRA SPINE SYSTEM
    K150185 Mont Blanc Spinal System
    K143684 NuVasive Reline System
    K143363 VENUS Spinal Fixation System
    K143731 IMPLANET Spine System (ISS)
    K143019 CD HORIZON Spinal System, IPC POWEREASE System
    K150507 Santis Pedicle Screw System
    K150325 Range/Denali/Mesa Spinal System
    K142531 F1-Modular Pedicle Screw System
    K150390 Nautilus Spinal System
    K142576 Spinal System
    K143230 Palladian Lumbar Pedicle Screw System
    K143375 CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
    K143569 CD HORIZON Spinal System
    K141222 NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
    K150178 CD HORIZON SPINAL SYSTEM
    K150092 STERISPINE PS Pedicle Screw
    K143200 MIS Z-Pedicle Screw System
    K143633 CREO Stabilization System
    K142360 Everest Spinal System
    K142939 Revolution Spinal Fixation System
    K143334 Range/Denali/Mesa Spinal System
    K141398 PASS LP SPINAL SYSTEM
    K143149 Arsenal Spinal Fixation System
    K141186 FIREBIRD SPINAL FIXATION SYSTEM
    K141695 ACROSSPINE PEDICLE SCREW SYSTEM
    K143248 Reform Pedicle Screw System
    K143403 Threshold Pedicular Fixation System
    K142737 MAS PLIF Fixation system
    K142146 IBIS PEDICLE SCREW SYSTEM
    K141282 PGS 5.5 MM CANNULATED PEDICLE SCREW
    K143141 CD HORIZON Spinal System
    K142591 CD HORIZON Spinal System
    K142499 Reline System
    K142185 EXPEDIUM VERSE SPINE SYSTEM
    K142847 CD HORIZON Spinal System
    K141850 FLOSPINE PEDICLE SCREW SYSTEM
    K142381 Xia 3 Spinal System
    K141604 CD HORIZON SPINAL SYSTEM
    K141804 POLARIS SPINAL SYSTEM - HA COATED
    K141873 RANGE/MESA/DENALI SPINAL SYSTEM
    K141291 VERTIFORM POSTERIOR FIXATION SYSTEM
    K141372 MERCURY SPINAL SYSTEM
    K141988 M.U.S.T PEDICLE SCREW SYSTEM
    K141044 M.U.S.T. EXTENSION
    K132049 THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS
    K141494 CD HORIZON SPINAL SYSTEM
    K133402 K2M MODULAR HOOKS
    K141605 CD HORIZON SPINAL SYSTEM
    K140765 RANGE/MESA/DENALI SPINAL SYSTEM
    K140802 STERISPINE PS
    K141147 RANGE SPINAL SYSTEM
    K140529 EVEREST SPINAL SYSTEM
    K140238 EXCELLA III-D SPINAL DEFORMITY SYSTEM
    K140123 POLARIS SPINAL SYSTEM -TRANSLATION SCREW
    K140010 FORTRESS PEDICLE SCREW SYSTEM
    K140219 PICASSO II MIS SPINAL SYSTEM
    K140696 STREAMLINE TL SPINAL FIXATION SYSTEM
    K133366 ORTHROS POSTERIOR STABILIZATION SYSTEM
    K133743 BAXANO SURGICAL MIS SPINAL SYSTEM
    K140457 NAUTILUS SPINAL SYSTEM
    K140449 CD HORIZON SPINAL SYSTEM
    K133944 RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
    K133221 ARSENAL SPINAL FIXATION SYSTEM
    K133746 POLARIS SPINAL SYSTEM
    K133350 REVERE STABILIZATION SYSTEM
    K133564 MODIFICATION TO NAUTILUS SPINAL SYSTEM
    K132925 SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK
    K133369 TIGER SPINE SYSTEM
    K133066 SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
    K133063 SANTIS PEDICLE SCREW SYSTEM
    K132878 M.U.S.T. EXTENSION
    K133291 ST360 DEGREES SPINAL FIXATION SYSTEM
    K133188 MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
    K132328 CD HORIZON SPINAL SYSTEM
    K133086 TITLE 2 POLYAXIAL SPINAL SYSTEM
    K132884 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
    K132639 CD HORIZON SPINAL SYSTEM
    K132603 APEX SPINE SYSTEM
    K132014 GSB GLOBAL SPINAL BALANCE SYSTEM
    K132866 NAUTILUS SPINAL SYSTEM
    K132471 CD HORIZON SPINAL SYSTEM
    K132760 NAUTILUS SPINAL SYSTEM
    K131250 TIGER SPINE SYSTEM
    K131980 SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
    K131878 LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
    K131785 PAGODA PEDICLE SCREW SYSTEM
    K130932 FIREBIRD SPINAL FIXATION SYSTEM
    K132111 CD HORIZON SPINAL SYSTEM
    K131100 STREAMLINE TL SPINAL SYSTEM
    K130877 EXPEDIUM SPINE SYSTEM
    K131119 SOLANAS POSTERIOR STABILIZATION SYSTEM
    K130632 STERISPINE PS PEDICLE SCREW
    K123552 INSTINCT JAVA SYSTEM
    K130291 S4 SPINAL SYSTEM
    K130646 CD HORIZON SPINAL SYSTEM
    K130286 STREAMLINE MIS SPINAL FIXATION SYSTEM
    K130176 FIREBIRD SPINAL FIXATION SYSTEM
    K123939 S4 SPINAL SYSTEM
    K123373 NAUTILUS SPINAL SYSTEM
    K123717 UCENTUM
    K123549 POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
    K123809 CD HORIZON SPINAL SYSTEM
    K123623 ILLICO MIS POSTERIOR FIXATION SYSTEM
    K123134 EASYSPINE SYSTEM
    K121670 MEDYSSEY CANNULATED PEDICLE SCREW
    K123352 S4 SPINAL SYSTEM
    K122571 MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
    K122845 ES2 SPINAL SYSTEM MODEL 48280XXXX
    K123451 POLARIS SPINAL SYSTEM - BALLISTA II RODS
    K122901 FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
    K122229 VICEROY SPINAL SYSTEM
    K123246 CD HORIZON SPIRE Z SPINAL SYSTEM
    K121786 DYMAXEON SPINE SYSTEM
    K121728 TIGER SPINE SYSTEM
    K122862 CD HORIZON SPINAL SYSTEM
    K122226 REVERE STABILIZATION SYSTEM
    K120891 TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
    K122433 CD HORIZON SPINAL SYSTEM
    K121568 DALI SPINAL FIXATION SYSTEM
    K122352 NUVASIVE PRECEPT SPINAL SYSTEM
    K121316 LANX SPINAL FIZATION SYSTEM
    K113666 XIA 3 SPINAL SYSTEM
    K121619 NUVASIVE POLYAXIAL SPINAL SCREWS
    K121103 LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
    K121764 CD HORIZON SPINAL SYSTEM
    K122145 LANX SPINAL FIXATION SYSTEM
    K120469 ERISMA-LP
    K120714 PICASSO MIS SPINAL FIXATION SYSTEM
    K111953 NAUTILUS SPINAL SYSTEM
    K121940 LANX SPINAL FIXATION SYSTEM
    K120838 SYNTHES MATRIX SYSTEM
    K121299 STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
    K120467 SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
    K121922 BEACON STABILIZATION SYSTEM
    K121671 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
    K120564 CALYPSO SYSTEM
    K121680 CD HORIZON SPINAL SYSTEM
    K121342 XIA 4.5 SPINAL SYSTEM
    K121130 POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
    K113395 REVERE 4.5 STABILIZATION SYSTEM
    K111136 EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
    K112607 SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
    K120829 STAINLESS STEEL SPINAL SYSTEM
    K120928 SYNTHES MATRIX SYSTEM
    K120091 R&D INNOVATION PEDICLE SCREW SYSTEM
    K120571 SYNTHES USS CONNECTOR
    K121020 VIPER SYSTEM
    K112684 MONT BLANC PEDICLE SCREW SYSTEMS
    K113361 SECURIS SPINAL FIXATION
    K113058 TIGER SPINE SYSTEM
    K120270 VENUS SPINAL FIXATION SYSTEM
    K120074 FOUNDATION SPINAL SYSTEM
    K120399 LANX SPINAL FIXATION SYSTEM
    K120434 POWER ADAPTOR INSTRUMENT ACCESSORY
    K120355 LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
    K111448 ICON (TM) MODULAR PEDICLE SCREW SYSTEM
    K120140 FOCUS SPINAL SYSTEM
    K113529 CD HORIZON VOYAGER SPINAL SYSTEM
    K113396 DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
    K120047 CORAL SPINAL SYSTEM
    K111634 XENON(TM) PEDICLE SCREW SYSTEM
    K113173 NANOVIS SPINAL SYSTEM
    K113366 LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
    K113625 DSS STABILIZATION SYSTEM
    K112643 FOCUS MIS SYSTEM
    K113044 SYNTHES MIRS
    K113434 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
    K113270 INSTINCT JAVA SYSTEM
    K110046 ATHENA PEDICLE SCREW SYSTEM
    K113174 CD HORIZON SPINAL SYSTEM
    K112551 S4 SPINAL SYSTEM
    K111358 SYNTHES USS
    K112453 STERISPINEPS PEDICLE SCREW
    K112931 LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM
    K110655 MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM
    K110551 EXPEDIUM SPINE SYSTEM
    K112473 CD HORIZON SPINAL SYSTEM
    K112759 APCLO PEDICLE SCREW SYSTEMS
    K112555 CD HORIZON(R) SPINAL SYSTEM
    K111510 CD HORIZON SPINAL SYSTEM
    K111457 CD HORIZON SPINAL SYSTEM
    K111729 PILOT SPINAL SYSTEM
    K111942 TSRH SPINAL SYSTEMS
    K111301 INSTINCT JAVA SYSTEM
    K111502 STREAMLINE TL SPINAL SYSTEM
    K111957 POLARIS SPINAL SYSTEM
    K111479 REVERE CROSSTOP
    K111449 REVOLVE ADDITIONAL IMPLANTS
    K111478 STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
    K110679 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
    K110906 APEX SPINE SYSTEM
    K103671 GENESYS SPINE TILOCK SYSTEM
    K110842 ATLAS SPINE PEDICLE SCREW SYSTEM
    K111076 SOLANAS AVALON POSTERIOR FIXATION SYSTEM
    K111571 VIPER SYSTEMS
    K110280 REVLOK FENESTRATED SCREW SYSTEM
    K110070 TSRH SPINAL SYSTEM
    K110588 LEUCADIA PEDICLE SCREW SYSTEM
    K110676 TSRH SPINAL SYSTEM
    K110692 STREAMLINE TL SPINAL SYSTEM
    K111099 ISSYS LP SPINAL FIXATION SYSTEM
    K110216 EXPEDIUM SYSTEM, VIPER SYSTEM
    K103237 LANX SPINAL SYSTEM
    K101971 SYNTEC OS SPINAL FIXATION SYSTEM
    K103072 REVERE SACRAL PLATES
    K101790 QUANTUM SPINAL SYSTEM, QUANTUM MIS
    K103292 TRIO TRAUMA SPINAL SYSTEM
    K103748 LAGUNA PEDICLE SCREW SYSTEM
    K103490 EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
    K103383 SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
    K103040 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
    K103133 VEPER SYSTEM, EXPEDIUM SYSTEM
    K103287 SYNTHES 6.0 COCR AND CPT TI-3 RODS
    K103049 TSRH SPINAL SYSTEM
    K102249 EXPEDIUM SPINE SYSTEM
    K101993 VIPER SYSTEM, EXPEDIUM SYSTEM
    K102514 NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
    K102807 CD HORIZON SPINAL SYSTEM
    K102555 CD HORIZON SPINAL SYSTEM
    K102204 CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
    K102701 VIPER SPINE SYSTEM
    K101933 MODIFICATION TO:EXPEDIUM SPINE SYSTEM
    K102248 EXCELLA II SPINAL SYSTEM MODEL EC2-00
    K101772 TSRH(R) SPINAL SYSTEM
    K091445 CD HORIZON SPINAL SYSTEM
    K100845 PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
    K101070 EXPEDIUM SPINE SYSTEM
    K102235 MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
    K100970 STAINLESS STEEL SPINAL SYSTEM
    K093692 QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
    K100935 LANX SPINAL FIXATION SYSTEM
    K100952 MODIFICATION TO SYNTHES MATRIX SYSTEM
    K093926 FIREBIRD SPINAL FIXATION SYSTEM
    K100147 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
    K101144 MODIFICATION TO:RADIUS SPINAL SYSTEM
    K100757 TILOCK PEDICLE SCREW SYSTEM
    K100634 SYNTHES MATRIX SYSTEM
    K100438 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
    K100409 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
    K101074 MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
    K100623 AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
    K100220 POLARIS SPINAL SYSTEM
    K100788 COCR RODS
    K094002 SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
    K091797 TSRH SPINAL SYSTEM
    K100737 MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
    K093668 SYNTHES MATRIX MIS RODS
    K093294 REVERE STABILIZATION SYSTEM
    K100044 FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
    K091717 ANY PLUS SPINAL FIXATION SYSTEM
    K092929 SYNTHES MATRIX SYSTEM
    K092325 MODIFICATION TO:CD HORIZON SPINAL SYSTEM
    K092605 XIA 4.5 SPINAL SYSTEM
    K093434 VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
    K092473 EXPEDIUM SPINE SYSTEM
    K090605 CLAMPFIX
    K092536 SPINAL FIXATION SYSTEM
    K093058 TSRH SPINAL SYSTEM
    K092287 NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
    K092676 TSRH SPINAL SYSTEM
    K092631 MANTIS REDUX SPINAL SYSTEM
    K092626 MODIFICATION TO: EXPEDIUM SPINE SYSTEM
    K092624 FIREBIRD SPINAL FIXATION SYSTEM
    K092610 MODIFICATION TO BEACON STABILIZATION SYSTEM
    K091974 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K090740 MODIFICATION TO: TSRH SPINAL SYSTEM
    K091782 REVERE 6.35 STABILIZATION SYSTEM
    K092073 MONOPOLY PEDICLE SCREW SYSTEM
    K091995 LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
    K070385 TI-TAMED SPINAL SYSTEM
    K090203 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
    K091502 NUVASIVE SPHERX II SYSTEM
    K090320 CONQUEST SPINAL SYSTEM
    K091442 CD HORIZON SPINAL SYSTEM
    K091067 5.5 POLARIS SPINAL SYSTEM
    K091219 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
    K090981 MODIFICATION TO: NUVASIVE SPHERX SYSTEM
    K083004 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
    K091587 MERCURY SPINAL SYSTEM
    K090523 POLARIS SPINAL SYSTEM
    K091291 XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
    K090099 DSS STABILIZATION SYSTEM
    K091266 THEKEN CORAL SPINAL SYSTEM
    K090648 VIPER 2 SYSTEM
    K090390 CD HORIZON SPINAL SYSTEM
    K090799 MODIFICATION TO EXPEDIUM SPINE SYSTEM
    K090657 MODIFICATION TO: S4 SPINAL SYSTEM
    K083393 XIA 3 SPINAL SYSTEM
    K090408 MODIFICATION TO: DSS STABILIZATION SYSTEM
    K083825 EOI SPINAL SYSTEM
    K090230 EXPEDIUM SPINE SYSTEM
    K082353 MERCURY SPINAL SYSTEM
    K083089 NEWPORT SPINAL SYSTEM
    K083416 REVOLVE STABILIZATION SYSTEM
    K082914 CLAMPFIX
    K083230 MERCURY SPINAL SYSTEM
    K082572 USS ILIOSACRAL, USS POLYAXIAL
    K081080 TSRH SPINAL SYSTEM
    K083028 MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
    K082942 MODFICATION TO: EXPEDIUM SPINE SYSTEM
    K082797 BLACKSTONE PEDICLE SCREW SYSTEM
    K082332 NUVASIVE SPHERX SYSTEM
    K082236 CD HORIZON SPINAL SYSTEM
    K082592 LDR SPINE EASYSPINE SYSTEM
    K082608 RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
    K081952 SYNERGY SPINAL SYSTEM (6.35 POLARIS)
    K082032 SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
    K081684 BLACKSTONE PEDICLE SCREW SYSTEM
    K081898 EXPEDIUM SPINE SYSTEM
    K082195 MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
    K081108 MONOPOLY PEDICLE SCREW SYSTEM
    K072678 LAGUNA SIZE 8 PEDICLE SCREW
    K081414 MODIFICATION TO CORAL SPINAL SYSTEM
    K062254 AXIS FIXATION SYSTEM
    K081252 EXPEDIUM 4.5MM SPINE SYSTEM
    K081195 REVERE UNIPLANAR SCREWS
    K073562 MODIFICATION TO VIPER SPINE SYSTEM
    K080313 MODIFICATION TO EXPEDIUM SPINE SYSTEM
    K080928 XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
    K073364 EXPEDIUM 4.5MM SPINE SYSTEM
    K080518 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
    K080504 PIONEER LOWTOP SPINAL ROD SYSTEM
    K072116 SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
    K080258 MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
    K073245 EXTENDED VERTIFLEX SPINAL SCREW SYSTEM
    K073510 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
    K073267 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
    K073430 VALEO PEDICLE SCREW SPINAL SYSTEM
    K073480 LIFE SPINE CROSS CONNECTOR
    K073517 H-LINK INTEGRATED ROD
    K072605 MALIBU SPINAL SYSTEM
    K073172 BEACON STABILIZATION SYSTEM
    K072840 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
    K073151 MANTIS SPINAL SYSTEM
    K073126 EXPEDIUM SPINE SYSTEM
    K072672 SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
    K072022 VALEO PEDICLE SCREW SPINAL SYSTEM
    K071921 INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
    K072426 ATLAS SPINE PEDICLE SCREW SYSTEM
    K071914 MERCURY SPINAL SYSTEM
    K072429 MODIFICATION TO TSRH SPINAL SYSTEM
    K071945 S4 SPINAL SYSTEM
    K072317 MODIFICATION TO:TSRH SPINAL SYSTEM
    K070387 EXPEDIUM SPINE SYSTEM
    K070282 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
    K072183 ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
    K071373 STRYKER SPINE XIA III SPINAL SYSTEM
    K070962 CORAL PEDICLE SCREW SYSTEM
    K071380 MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
    K071860 MODIFICATION TO: VIPER SPINE SYSTEM
    K071174 PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
    K070631 DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
    K063772 EXPEDIUM SPINE SYSTEM
    K070973 QUANTUM SPINAL SYSTEM
    K071495 EXPEDIUM 4.5MM SPINE SYSTEM
    K063670 MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
    K070995 ARX-LINK CROSS CONNECTOR
    K071376 MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
    K070460 ALLEZ SPINE CROSS CONNECTORS
    K070281 ISSYS LP SPINAL FIXATION SYSTEM
    K070368 TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
    K070367 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
    K070551 MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
    K062327 MODIFICATION TO S4 SPINAL SYSTEM
    K062085 S4 SPINAL SYSTEM
    K062012 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
    K063417 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K063741 EXPEDIUM SPINE SYSTEM
    K063428 XIA STAINLESS STEEL SPINAL SYSTEM
    K063156 MODIFICATION TO EXPEDIUM SPINE SYSTEM
    K062270 RADIUS SPINAL SYSTEM
    K063083 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K062807 TSRH SPINAL SYSTEM
    K061342 MALIBU SPINAL SYSTEM
    K060615 CD HORIZON SPINAL SYSTEM
    K062685 EBI ARAY SPINAL SYSTEM
    K061854 XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
    K061202 REVERE STABILIZATION SYSTEM
    K061592 MODIFICATION TO CD HORIZON SYSTEM
    K061563 EBI ARRAY SPINAL SYSTEM
    K061520 VIPER SPINE SYSTEM
    K060979 XIA TITANIUM AND 4.5 SPINAL SYSTEMS
    K060990 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
    K060748 MODIFICATION TO XIA 4.5 SPINAL SYSTEM
    K060361 XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
    K060203 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K053474 CD HORIZON SPINAL SYSTEM
    K053101 CD HORIZON SPINAL SYSTEM
    K053276 IST PEDICLE SCREW SYSTEM
    K052385 TANGORS POLYAXIAL SYSTEM
    K051275 LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
    K052151 SYNTHES PANGEA MONOAXIAL SYSTEM
    K052747 MODIFICATION TO:CD HORIZON SPINAL SYSTEM
    K052609 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K052144 TSRH SPINAL SYSTEM
    K052187 MODIFICATION TO: CD HORIZON SPINAL SYSTEM
    K052054 TSRH SPINAL SYSTEM
    K051674 CD HORIZON SPINAL SYSTEM
    K051663 MALIBU SPINAL SYSTEM
    K051024 EXPEDIUM SPINE SYSTEM
    K050439 CD HORIZON SPINAL SYSTEM
    K043488 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K050282 MODIFICATION TO TSRH SPINAL SYSTEM
    K043321 MODIFICATION TO: CD HORIZON SPINAL SYSTEM
    K043232 UCR SPINAL SYSTEM
    K042962 MODIFICATION TO CD HORIZON SPINAL SYSTEM
    K042772 EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE
    K042702 SILHOUETTE SPINAL FIXATION SYSTEM
    K042953 MODIFICATION TO PROTEX STABILIZATION SYSTEM
    K042886 CD HORIZON SPINAL SYSTEM
    K042790 CD HORIZON SPINAL SYSTEM
    K042167 MODIFICATION TO: CD HORIZON SPINAL SYSTEM
    K041801 EXPEDIUM MIS SPINE SYSTEM
    K041167 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
    K033901 MERLIN SPINE SYSTEM
    K032560 ARROWHEAD SPINAL SYSTEM
    K033312 EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
    K032033 CD HORIZON SPINAL SYSTEM
    K030369 OPUS SPINAL SYSTEM
    K031424 EBI SPINELINK SPINAL FIXATION SYSTEM
    K031355 EBI SPINELINK - II SPINAL FIXATION SYSTEM
    K030087 SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
    K030625 SPINAL CONCEPTS INC. PATHFINDER
    K030285 MODIFICATION TO TSRH SPINAL SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 407 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 407 registration numbers. Click on an entry to view related FDA registrations.